Bimatoprost

Mean intraocular pressure (IOP) was reduced by 43.7% from baseline at month 18All patients remained off topical IOP-lowering medications and achieved >20% IOP reductionAll eyes achieved Visual Acuity (BCDVA) of 20/30 or better ALISO VIEJO, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) -- SpyGlass Pharma™, a privately-held ophthalmic biotechnology company, released 18-month follow-up data from a first-in-human study of 23 patients with glaucoma or ocular hypertension implanted with the SpyGlass Intraocular Lens (IOL) based Drug Delivery Platform at the time of cataract surgery. These data were presented today during the Eyecelerator Ophthalmic Innovation Conference prior to the American Academy of Ophthalmology annual meeting in Chicago, Ill. The sustained reduction of intraocular pressure (IOP) was consistent across all three dose strengths, achieving a mean pressure reduction of 43.7% at month 18 compared with baseline. Additionally, 100% of patients remained off all topical IOP-lowering drops. All patients achieved an IOP reduction of more than 20% from baseline and 96% of patients maintained an IOP ≤18 mmHg through month 18. The SpyGlass platform was well-tolerated and there were no product related adverse events. “The clinical results achieved by the SpyGlass Drug Delivery Platform, now 18 months post implantation, continue to be compelling for ophthalmic surgeons and for patients living with glaucoma,” said Malik Kahook, M.D., Co-founder of SpyGlass Pharma™. “Long-term drug delivery of trusted medicine is a major unmet need for patients living with chronic eye conditions. The results presented showcase the potential of the SpyGlass Drug Delivery Platform to be a game changer for glaucoma patients and all cataract surgeons.” “The SpyGlass technology continues to demonstrate great potential for improving care in glaucoma patients undergoing routine cataract surgery,” said Patrick Mooney, CEO, SpyGlass Pharma™. "Approximately 1 million cataract surgeries are performed each year in patients with glaucoma or ocular hypertension in the United States alone. Beyond our compelling clinical data, the SpyGlass technology is implanted utilizing standard surgical techniques that every cataract surgeon knows by heart. So often, new technology requires new surgical skills to learn, which can limit surgeon adoption. With SpyGlass technology, cataract surgeons will use their proven implantation techniques which makes the potential adoption of SpyGlass’ Drug Delivery Platform three times greater than existing interventional glaucoma devices in market today.” ABOUT SPYGLASS PHARMA The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. Patients in the first-in-human study will continue to be followed over time, and the Company plans to share longer-term data in the coming months. SpyGlass is on track to complete enrollment this year in a Phase I/II study in the United States to investigate the safety and efficacy of its platform in a larger patient pool. SpyGlass looks forward to working closely with the U.S. Food and Drug Administration (FDA) to advance the program to commercial approval. SpyGlass Pharma was co-founded by Dr. Malik Y. Kahook, M.D. and Glenn Sussman. The company is focused on the development of the world’s first, IOL-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy. The technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and spun off campus post Series A funding. http://www.spyglasspharma.com Media Contact: Angela Salerno-Robin 312-545-9331 asalerno-robin@dna-comms.com

Press Release Nicox Provides Third Quarter 2024 update and First Half 2024 Financial Results Topline results from the NCX 470 (bimatoprost grenod) Phase 3 Denali clinical trial expected in Q3 2025Cash of €19.7 million on September 30, 2024, including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024The Company estimates that it is financed into Q3 2025 October 17, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the revenue and cash position for Nicox SA and its subsidiaries (the “Nicox Group”) for the third quarter of 2024 and financial results for Nicox SA (the “Company”) for the first half of 2024, as approved by the Board of Directors on October 16, 2024 and provided an update on key future milestones. As previously announced, the Company is no longer reporting consolidated accounts under IFRS standards and figures communicated for the Nicox Group are for information only. “The first 9 months of 2024 have been a period of significant strategic progress for Nicox, in which we have stabilized our financial situation with a royalty sale, optimised our cost structure to focus on our lead asset and partnerships, renewed the Board of Directors and increased our institutional shareholder base through targeted financing activities. Our development team has also continued driving the NCX 470 Denali clinical trial with the completion of recruitment in the United States in July, and the target date for topline results now advanced to Q3 2025.” said Gavin Spencer, Chief Executive Officer of Nicox. “We have also seen major progress in our partnership activity, with our Chinese licensee Ocumension Therapeutics obtaining approval for ZERVIATE in China, where we are now awaiting the commercial launch, and the signature of a new research agreement, including a pre-agreed license option, for NCX 1728 with leading ophthalmic pharmaceutical and medical technology company Glaukos. Going forward we will be focussing on the completion of the Denali trial and partnerships for the commercialisation of NCX 470 in the United States and elsewhere.” Key Future Milestones Launch of ZERVIATE in China by Nicox’s partner, Ocumension Therapeutics: Approval obtained in September 2024. Whistler Phase 3b clinical trial, initiated in December 2023, investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure lowering: results are currently expected in the first quarter of 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: recruitment of the last patient in the U.S. in the Denali trial was in July when overall recruitment was approaching the 95% level, with recruitment continuing in China and topline results are expected in Q3 2025. Management ChangeEmmet Purtill, Vice President of Business Development at Nicox, has joined the Executive Committee. Emmet has been with the company since 2006 and has played a significant role in establishing our partnerships, notably the relationships with Ocumension and Kowa, and had led many of our recent deals. Emmet joins Sandrine Gestin, VP Finance and HR, Doug Hubatsch, Chief Scientific Officer and Gavin Spencer, Chief Executive Officer, who are the other Executive Committee members.Revenue, Cash Position for the Nicox Group for the Third Quarter 2024 and post-period events Due to the sale of the VYZULTA royalty, the Nicox Group received no material revenue in the third quarter of 2024 compared to €1.8 million (net revenue1 €1.1 million, entirely composed of net royalties) for the first quarter 2023.$16.5 million Royalty and Equity Financing with Soleus announced on October 14, 2024.Cash of €19.7 million at 30 September 2024 including the estimated net proceeds from the VYZULTA royalty sale and accompanying investment mentioned above, after deduction of legal, banking and other fees, compared to €7.7 million at 30 June 2024. Based on this cash position, expected milestone income from existing agreements, and accounting for the €5.2 million debt repayments by June 2025, the Company estimates that it is financed into Q3 2025. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. The Company cannot guarantee that it is financed to the topline results of the Denali trial, and completion of the Denali clinical trial may require additional financing.As of September 30, 2024, the Nicox Group had financial debt of €20.4 million (entirely held by Nicox SA), consisting of €19.4 million in the form of a bond financing agreement with Kreos Capital (an affiliate of BlackRock), and a €1.0 million credit agreement guaranteed by the French State, and granted in the context of the COVID-19 pandemic. Nicox will be repaying €5.2 million of the Kreos Capital debt by June 2025.The Company continues to evaluate all options for non-dilutive and dilutive financing to extend its cash runway. In particular the Company is actively exploring multiple strategic options which could facilitate the development and commercialization of its product candidate NCX 470 and the future growth of the Company. First Half 2024 Financial Results for Nicox SA Net revenue1 for the first half of 2024 was €4.9 million (including €1.7 million of net royalty payments and a license payment of €3.0 million) versus €1.7 million (consisting entirely of net royalty payments) for the first half of 2023. Operating expenses for the first half of 2024 were €10.1 million compared to €14.8 million for the first half of 2023. The decrease in operating expenses for the first half of 2024 compared with the first half of 2023 is explained by the costs related to the finalization of the Mont-Blanc study which had an impact on the first half of 2023. In addition, operating expenses for the first half of 2023 included a €3.5 million adjustment relating to the rebilling of services performed in 2022 by the U.S. subsidiary.Net loss for the six months ended June 30, 2024, was €4.4 million, compared to a net loss of €12.5 million for the same period in 2023. The reduction in the net loss for the first half of 2024 is mainly due to the increase in revenues following the signature of the agreement with Kowa for Japan for which the Company has received an initial payment of €3 million, and to the reduction in operating expenses as explained above.As of June 30, 2024, Nicox SA had cash and cash equivalents of €7.7 million as compared with €11.3 million as of December 31, 2023. Including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024 and exclusively on the basis of the development of NCX 470, the Company estimates it is currently funded into Q3 2025. As of June 30, 2024, Nicox SA had financial debt of €20.5 million, consisting of (i) €19.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and (ii) a €1.1 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.Only the figure related to the cash position and the debt of Nicox SA as of December 31, 2023, is audited; all other figures in this press release are non-audited. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. . Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2023” which is available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Income Statement (in thousands of euros) June 30, 2024June 30, 2023Sales of services – Various re-invoicing 23Royalties for patent grants 6 0672 721REVENUE 6 0692 724Reversals of depreciation, amortization, provisions and transfers of expenses 4497Other income 10577TOTAL OPERATING INCOME 6 6232 807Other purchases and external charges (6 853)(12 049)Taxes, duties and similar payments (42)(63)Salaries and wages (1 548)(918)Social security expenses (412)(361)Amortization (9)(11)Provisions for liability and charges -(108)Other expenses (1 190)(1 189)Exchange loss on receivables and debts (57)(130)TOTAL OPERATING EXPENSES (10 111)(14 829) OPERATING PROFIT (LOSS) (3 488)(12 022)Other interest and similar income 398550Reversal of provisions, impairment losses and transfer of expenses 1339Foreign exchange gains 23110TOTAL FINANCIAL INCOME 434699Amortization, depreciation and financial provisions (311)(306)Interest and similar expenses (789)(790)Foreign exchange loss -(212)Interests on loan (28)(29)Net expense from sales of investments securities (72)(185)TOTAL FINANCIAL EXPENSES (1 200)(1 522) FINANCIAL PROFIT (LOSS) (766)(823) PRE-TAX LOSS (4 254)(12 845)Exceptional income on management operations 3-Exceptional income from previous financial year -63EXCEPTIONAL INCOME 363 EXCEPTIONAL INCOME (LOSS) (23)63Research tax credit -251NET PROFIT & LOSS (4 277)(12 531) Balance sheet June 30, 2024December 31, 2023(in thousands of euros) ASSETS Intangible fixed assets1824Tangible fixed assets1426Financial fixed assets1 7291 805 FIXED ASSETS1 7611 855 Trade receivables and related accounts3 0223 424Other receivables (1)34 98434 324Cash assets7 65411 259Prepaid expenses1 207886 CURRENT ASSETS46 86749 893 Unrealized foreign exchange losses and valuation differences – Assets713Loan redemption premiums9141 218 TOTAL REGULARISATION ACCOUNTS9211 231 TOTAL ASSETS49 54952 979 LIABILITIES Share Capital63550 170Premiums related to share capital532 068529 478Retained earnings(508 438)(537 354)Net loss for the financial year(4 277)(20 881) Total shareholders' equity19 98821 413 Provisions for liabilities713Provisions for charges256700 Total provisions for liabilities and charges263713 Loans and debts from lending institutions20 53620 895Loans and other financial debts3 1564 258Accounts payable and related accounts1 5802 498Tax and social security debts515648Deferred income1 9951 919 Total current liabilities27 78230 218 Unrealized exchange gains1 516635 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY49 54952 979 1 Net revenue consists of revenue from collaborations less royalty payments Attachment EN_H1&Q32024_PR_FINAL